The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed on behalf of investors who acquired Capricor Therapeutics, Inc. (“Capricor” or the “Company”) (NASDAQ: CAPR) common stock between December 17, 2025 and July 26, 2026, inclusive (“the Class Period”).
If you suffered a loss on your Capricor investments, you have until September 28, 2026 to request lead plaintiff appointment. Courts do not consider lead plaintiff applications submitted after this deadline. If you choose to take no action, you may remain an absent class member. For more information about the lawsuit:
[CONTACT THE FIRM IF YOU SUFFERED A LOSS]
What Is This Lawsuit About? The lawsuit alleges that Capricor made materially false and/or misleading statements and failed to disclose to investors that: (i) the Company adopted changes to the pre-specific statistical analysis plan used to analyze clinical data for its lead product candidate, Deramiocel; (ii) the FDA had not agreed to those changes before the Company resubmitted the Deramiocel Biologics License Application (“BLA”); (iii) as a result, there was a significant risk that the FDA could conclude the clinical results did not provide substantial evidence of the effectiveness of Deramiocel; and (iv) as a result, there was substantial risk to regulatory approval of Deramiocel for the treatment of Duchenne muscular dystrophy.
On July 27, 2026, the FDA released briefing documents prior to its advisory committee meeting for the Deramiocel BLA, which revealed that Capricor made changes to the pre-specified statistical analysis plan and that the final version “was not submitted to FDA for review prior to BLA submission and was not discussed and consequently not agreed upon.”. The FDA disagreed with the changes and stated, “the benefit-risk assessment for Deramiocel appears unfavorable in the absence of evidence of effectiveness.” On this news, Capricor’s stock price fell $12.70, or 64%, to close at $7.00 per share on July 27, 2026.
On July 30, 2026, Medscape reported that the FDA advisory committee, which met on July 29, 2026, voted 9-3 to conclude “that the available evidence does not support the efficacy of Deramiocel for treating DMD-associated cardiomyopathy.” On this news, Capricor’s stock price fell $2.38, or 36%, to close at $4.19 per share on July 30, 2026.
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The Lead Plaintiff Appointment Process. The federal securities laws permit any investor who acquired eligible securities during the class period to seek appointment as lead plaintiff in a class action lawsuit. Learn more about the lead plaintiff process and eligibility requirements here. Courts typically appoint the investor(s) with the largest financial loss in the case and the ability to represent the class rather than investors with simply the largest investment portfolio. Courts regularly appoint individual investors, whether acting alone or as a group, as lead plaintiffs. The rights of any investor who bought shares during the class period are generally already protected. However, lead plaintiffs have the power to influence case strategy and have a say in settlement decisions, as well as decisions concerning allocation of settlement funds among class members.
[LEARN MORE ABOUT THE LEAD PLAINTIFF PROCESS]
What Should I Do? If you purchased or otherwise acquired Capricor securities, have information, or would like to learn more about this investigation, please contact Lauren Molinaro of Kirby McInerney LLP by email at investigations@kmllp.com, or fill out the contact form below, to discuss your rights or interests with respect to these matters at no cost.
Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP’s website.
This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260803442793/en/
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